The CTD and eCTD Formats for NDA & BLA Submissions

Description

Review of FDA and ICH guidance for NDAs/BLAs
Strategies for Navigating the Submissions and Review Processes
Supplements and Reports
Examining the Basic CTD Format (Modules 1â€”5)
Considerations for Regional Differences
Content Preparation Considerations for Modules
Best Practices for CTD Project Coordination and Management
Current Issues for eSubmissions to Health Canada and the FDA
Considerations for Applying Tools and Software for eCTD Submissions
Strategies and Steps for Transferring to Electronic Format
Validations Issues, Requirements and Tools
Best Practices for Producing/Publishing a BLA/NDA in eCTD Format
Filing eCTDs and Administering eSubmissions
CTD and eCTD Life Cycle Management
Co-Authoring and Preparing Submission-Ready Documents
Organizational impact of transitioning to eCTD